Amlodipine besylate tablet

Ingredients and appearance - Product information

Amlodipine besylate tablet- Amlodipine besylate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 48433-308
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Amlodipine besylate ( UNII: 864V2Q084H)( Amlodipine - UNII: 1J444QC288 ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color WHITE Size 8 mm
Shape ROUND Score 1
Imprint Code 2109;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078414 USA

Labeler - Safecor Health, LLC( 828269675)

Establishment

Name ID/FEI Business Operations
Safecor Health, LLC 828269675 REPACK( 48433-308)
These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
Based on patient weight of 50 kg.
Based on patient weight of 50 kg
Total patients with these events
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